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Trastuzumab and Combination Chemotherapy in Treating Patients With Locally Recurrent or Metastatic Urinary Tract Cancer

This study has been completed.

Sponsors and Collaborators: University of Michigan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005831
  Purpose

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with combination chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with combination chemotherapy in treating patients who have locally recurrent or metastatic urinary tract cancer.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Drug: trastuzumab
Phase II

Genetics Home Reference related topics:   bladder cancer   

MedlinePlus related topics:   Bladder Cancer    Cancer   

Drug Information available for:   Carboplatin    Gemcitabine hydrochloride    Gemcitabine    Paclitaxel    Trastuzumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Evaluation of Trastuzumab (Herceptin), Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Urothelial Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 2000
Primary Completion Date:   August 2004 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the toxicity of the combination of trastuzumab (Herceptin), paclitaxel, carboplatin, and gemcitabine in patients with HER2-overexpressing locally recurrent or metastatic urothelial carcinoma.
  • Determine the complete and partial response rates in patients treated with this regimen.
  • Determine the median and overall survival of patients treated with this regimen.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15; paclitaxel IV over 3 hours and carboplatin IV over 15 minutes on day 1; and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 3 weeks. Patients achieving a complete response (CR) receive 3 courses past CR. Patients achieving a partial response or stable disease continue on therapy until CR or disease progression or unacceptable toxicity.

Patients are followed for disease progression and survival. Patients with HER2-negative disease are not eligible for treatment but are followed every 6 months for response and survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 24 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally recurrent or metastatic urothelial carcinoma incurable by surgery or radiotherapy

    • Transitional cell OR squamous cell
  • HER2 overexpression of the primary or metastatic site evidenced by 1 of the following:

    • 2+ or 3+ staining by immunohistochemistry
    • Positive FISH defined as greater than 2 with the Vysis system or greater than 4 with the Ventana system
    • Elevated serum HER2 greater than 16 ng/mL with the OSDI assay
  • Biopsy-proven HER2 overexpression of metastatic site if primary site is histologically and serologically HER2 negative*
  • Bidimensionally measurable or evaluable disease

    • Disease outside previously irradiated fields NOTE: *HER2-negative patients are not eligible for treatment but are followed for response and survival

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Granulocyte count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No significant cardiac disease
  • Ejection fraction at least 50% by MUGA or 2D echocardiogram
  • No evidence of symptomatic coronary artery disease
  • No active ischemia on EKG
  • No history of congestive heart failure

Other:

  • No active bacterial infection
  • No other prior malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ
  • HIV negative
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy for metastatic disease
  • At least 6 months since prior adjuvant chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005831

Locations
United States, Arizona
Mayo Clinic Scottsdale    
      Scottsdale, Arizona, United States, 85259
United States, California
University of California Davis Cancer Center    
      Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center    
      Denver, Colorado, United States, 80010
United States, Michigan
University of Michigan Comprehensive Cancer Center    
      Ann Arbor, Michigan, United States, 48109-0942
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University    
      New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Taussig Cancer Center    
      Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute    
      Pittsburgh, Pennsylvania, United States, 15213-3489

Sponsors and Collaborators
University of Michigan Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Maha Hadi A. Hussain, MD     University of Michigan Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067845, CCUM-9955, WSU-C-2078, NCI-198
First Received:   June 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005831
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III bladder cancer  
recurrent bladder cancer  
stage IV bladder cancer  
transitional cell carcinoma of the bladder  
squamous cell carcinoma of the bladder  
recurrent urethral cancer
urethral cancer associated with invasive bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter

Study placed in the following topic categories:
Squamous cell carcinoma
Ureteral Diseases
Urogenital Neoplasms
Urologic Neoplasms
Carcinoma, Transitional Cell
Kidney cancer
Urologic Diseases
Kidney Neoplasms
Trastuzumab
Carcinoma, squamous cell
Kidney Diseases
Gemcitabine
Bladder neoplasm
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Carboplatin
Renal cancer
Transitional cell carcinoma
Recurrence
Carcinoma
Epidermoid carcinoma
Urethral cancer
Paclitaxel
Urethral Neoplasms
Carcinoma, Squamous Cell
Ureteral Neoplasms
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators
Urethral Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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